Sustainable Weight Loss Study: Nutrition Support Tools and Weight Loss Among Obese People

NCT ID: NCT04378322

Last Updated: 2020-05-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-04
• Study Completion Date: 2022-07-31

Brief Summary

The purpose of this research study is to determine the effectiveness of nutrition tools to support weight loss among obese individuals. All participation will be based online and there will be no in-person visits. Participants will be given nutrition support tools for 6 months. Participants will be asked to report their weight and diet at the start of the study, and every month for 6 months during the study period. Participants will additionally be asked to report weight and diet at 12 months, 18 months, and 24 months after the start of the study. Total study duration will be 2 years.

Detailed Description

Obesity is a major public health burden. Weight loss among obese participants may improve future health outcomes and financial burden to the healthcare system and employers.

The effect of personalized meal planning and online food purchasing and delivery on weight loss and management is unknown.

Design: This trial is an online, three-arm randomized trial to compare a meal planning and telenutrition tool, a meal planning tool only, and MyPlate optimization.

Participants will be assigned to randomly assigned in a 1:1:1 ratio to one of the three groups.

Participants will follow the intervention for 6 months after randomization and will be followed for an additional 1.5 years after randomization.

Participants will report dietary behavior and weight at baseline and each month of the intervention (6 months), 12 months, 18 months, and 24 months.

Population Approximately 300 participants will be enrolled and randomized (100 per arm). Participants will be adults living in New York state who are obese (at least a BMI of 30 kg/m2).

Outcomes Primary outcome: weight change after 6 months Other outcomes: waist circumference; blood pressure, dietary changes, cooking, meal planning, and eating out frequencies

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Nutrition and food purchasing tool + telenutrition

Participants will use an online nutrition and food purchasing tool in addition to telenutrition.

Group Type: ACTIVE_COMPARATOR

Nutrition and food purchasing tool + telenutrition

Intervention Type: BEHAVIORAL

Participants will be asked to use a meal planning and food purchasing feature regularly (at least once every two weeks) and schedule appointments with a registered dietitian.

Nutrition and food purchasing tool

Participants will use an online nutrition and food purchasing tool.

Group Type: ACTIVE_COMPARATOR

Nutrition and food purchasing tool

Intervention Type: BEHAVIORAL

Participants will be asked to use a meal planning and food purchasing feature regularly (at least once every two weeks).

Nutrition education tool

Participants will be exposed to an online nutrition education materials.

Group Type: ACTIVE_COMPARATOR

Nutrition education tool

Intervention Type: BEHAVIORAL

Participants will be asked to review nutrition education materials online.

Interventions

Nutrition and food purchasing tool + telenutrition

Participants will be asked to use a meal planning and food purchasing feature regularly (at least once every two weeks) and schedule appointments with a registered dietitian.

Intervention Type: BEHAVIORAL

Nutrition and food purchasing tool

Participants will be asked to use a meal planning and food purchasing feature regularly (at least once every two weeks).

Intervention Type: BEHAVIORAL

Nutrition education tool

Participants will be asked to review nutrition education materials online.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

BMI ≥ 30 kg/m2 Male or female 18 or older Non-institutionalized Able and willing to provide informed consent Willing to change diet for 3 months Has access to a scale to weigh themselves Lives in NY state

Exclusion Criteria

Refuse or are unable to provide informed consent to participate in the study Undergoing active cancer treatment Has type 1 or 2 diabetes Stage 3+ CKD or kidney failure Are pregnant or breastfeeding, have given birth in the last three months, or are planning to be pregnant in the next 3 months Report of congestive heart failure Diagnosed with an eating disorder (e.g. anorexia nervosa or bulimia nervosa) Current or former Zipongo users

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zipongo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

102

Identifier Type: -

Identifier Source: org_study_id